A Phase 1 interventional study of Psilocybin (drug) and Dextromethorphan (DXM) in Anhedonia in Healthy Volunteers and Older Adults (50-90 Years), sponsored by Jennifer Mitchell. Recruiting at 1 site in United States. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Jennifer Mitchell · Phase 1, Interventional, and Treatment
Among 59 studies in Neuroinflammatory Diseases with a site in United States — 21 open to participants now, 26 under way, none of them phase 3. Neuroinflammatory Diseases · United States.
Among the 59 studies in Neuroinflammatory Diseases with a site in United States, this one is the 5th largest by planned enrollment of the 38 interventional ones that give a count, is one of 12 that started in 2026, is one of 11 in phase 1, reaches primary completion later than 22 of the 25 other live ones, and was the 51st registered.
180 studies on the registry are indexed under Neuroinflammatory Diseases; 80 are open to participants now.
Browse Neuroinflammatory Diseases studies →21 of the 59 studies in Neuroinflammatory Diseases with a site in United States are open now. Recruiting first, the newest first:
University of Miami · Sites in United States
Ages 50+
National Institute of Mental Health (NIMH) · Sites in United States
Ages 1 mo–100 yrs
Summit Hyperbarics and Wellness · Sites in United States
Ages 18–75
Sundance Biosciences, Inc. · Sites in United States
Ages 18–70
Washington University School of Medicine · Sites in United States
Ages 40–70
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 53 Neuroinflammatory Diseases studies recruiting now, 16 (30%) set no upper age limit and 24 (45%) stop at 75 or younger; 11 take children under 18; 17 take healthy volunteers.
This study: 50 Years to 85 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
59 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 17 · Phase 3 1 · Phase 4 2
First in 2005; this study’s year is marked. 12 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 80 is above the median of 44 across 113 interventional studies indexed under Neuroinflammatory Diseases.
Median enrollment 30 across the 38 interventional studies, 65 across the 21 observational. Of the 30 that completed or were terminated, 9 (30%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 59 have an industry lead sponsor. The 10 most frequent:
Jennifer Mitchell is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Jennifer Mitchell has 1 study filed under Neuroinflammatory Diseases — fewer than ten, so there is no comparison to draw.
9 of the studies in Neuroinflammatory Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02435810National Institute of Neurological Disorders and Stroke (NINDS)Inflammatory and Infectious Diseases of the Nervous System | 2026-11-29 |
| NCT05020535Johns Hopkins UniversityBiomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) | 2026-11-30 |
| NCT05350774National Institute of Neurological Disorders and Stroke (NINDS)Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2 | 2026-12-15 |
| NCT07651787University of OklahomaUsing Light Therapy for Mild Cognitive Impairment | 2026-12-31 |
| NCT07303933Penn State UniversityFemale Concussion Head Cooling | 2027-01-01 |
Add all 9 to your calendar (.ics) → With an account.
Among the 59 studies in Neuroinflammatory Diseases with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being.
The main questions it aims to answer are, does psilocybin:
Participants will be in the study for up to 3 months, which will include 3 to 4 in person visits and 3 to 4 remote visits. Most visits will be between 1 to 3 hours, but the dosing visit will last a minimum of 8 hours and could be as long as 12 hours. During the dosing visit, all participants will receive a single dose of the study drugs and dosages listed below.
Researchers will compare participants who receive the following drug options:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The eligibility criteria are deliberately incomplete to preserve the scientific integrity of the study.
Inclusion Criteria:
Exclusion Criteria:
General:
MRI Exclusions:
Psychiatric:
•History of hallucinogen persisting perception disorder (HPPD) (as per criteria)
Cardiovascular:
General health:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single low-to-moderate dose of Psilocybin (5-10 mg)
Drug: Psilocybin (drug)
A single moderate-to-high dose of Psilocybin (25-30 mg)
Drug: Psilocybin (drug)
A single low-to-moderate dose of Dextromethorphan (30-60 mg)
Drug: Dextromethorphan (DXM)
A single moderate-to-high dose of Dextromethorphan (80-90 mg)
Drug: Dextromethorphan (DXM)
Participants will receive either Psilocybin or Dextromethorphan in this clinical trial
Participants will receive either Psilocybin or Dextromethorphan in this clinical trial
Acute changes in EEG-based ESBA
Compare acute changes in EEG-based Lempel Ziv complexity (pre- to post-dose, arbitrary unit) between the four study arms, with the presence of biomarkers of AD pathology used in the statistical analyses as a moderator. Lempel-Ziv complexity in EEG is a non-linear analysis tool that quantifies the amount of entropy of spontaneous brain activity (ESBA).
Time frame: Pre- to post-dose two hours later
Changes in TNF-alpha
Compare changes in a biomarkers of neuroinflammation (TNF-alpha) psilocybin across the four study arms, with the presence of biomarkers of AD pathology used in the statistical analyses as a moderator. Reference Range 0.56-1.40 pg/mL
Time frame: Screening to three weeks post dosing
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Feb 2030, 44 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Psilocybin · Dextromethorphan
Jennifer Mitchell